Associate Director, Study Management

Precision for Medicine•Frederick, MD

3d•$147,300 - $220,900

About The Position

The Associate Director, Study Management directs the delivery of study milestones across multiple scientific teams, ensuring work meets cost, time, quality, and scope requirements. The role provides strategic leadership to direct and indirect reports, external partners, consultants, and financial budgets. It oversees Project Directors responsible for leading scientific work supporting assay analysis for non-regulated, GLP-regulated, GCP-regulated, and commercial diagnostic (CLSI, CLIA) studies across Bioanalytical, Companion Diagnostic, Flow Cytometry, and Cell Biology teams. As a subject matter expert, the Associate Director applies knowledge of industry, customer requirements, and the business environment to guide strategic actions. The role works with scientific and operational leaders to improve business processes and establish consistent operational standards. It leads study teams and serves as the authoritative source of study information, accountable for timelines, budgets, quality, communications, and deliverables. The position also manages Project Director performance and development, handles initial customer escalations, and works with customers and senior leaders to address risks and contingencies. The role requires a master's degree in a life science or related field, at least eight years of project management experience, and at least three years of management responsibility, or an accepted equivalent combination of education, training, and related experience. A discretionary annual bonus and benefits including health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off for sick leave and vacation are offered. The compensation range is $147,300–$220,900 USD.

Requirements

Master's degree in a life science or related field, such as engineering, and at least 8 years of project management experience and 3 years of management responsibility; an equivalent combination of appropriate education, training, and directly related experience may be accepted in some cases.
Outstanding leadership skills.
Excellent judgment and decision-making skills.
Direct experience overseeing ELISA, MSD, and Nab assays.
Experience working in a regulated environment, preferably GLP or GCP.
Superior knowledge of project management principles and their application.
Extensive financial acumen, including broad knowledge of budgeting, forecasting, and resource management.
Knowledge of regulatory guidelines and directives.
Superior process-improvement skills, especially as applied to project management.
Knowledge of laboratory practices and terminology.
Ability to read, write, speak, and comprehend English fluently.
Proven record of being a proactive and productive team player.
Legally authorized to work in the country of employment without employer sponsorship.

Nice To Haves

Master's or PhD in Biology, Biochemistry, Immunology, Cell Biology, Molecular Biology, or a related field.
Experience in cellular, molecular, or biochemical science, such as hands-on research or laboratory experience in cellular biomarker analysis, protein-based assays, next-generation sequencing, IHC, or PK/PD assays.
Experience with project management software.

Responsibilities

Apply industry, customer, and business knowledge to adapt and implement strategic actions for the team.
Collaborate with senior scientific and operational leadership to develop and improve business processes for cross-functional teams.
Set objectives for and manage multiple projects and ongoing activities across PFM Specialty Lab teams.
Serve as the authoritative source of study information and lead client study status reporting.
Lead study teams and deliverables across functions, managing timelines, budgets, and quality targets.
Ensure effective study team scheduling, recordkeeping, and communications.
Define operational strategy, timelines, resourcing, and budget needs within the study scope of work.
Establish operational standards and best practices across the Project Director team and ensure adherence.
Partner with business unit leaders to assess development program timelines and budgets and inform opportunity assessments.
Review annual objectives and development plans and conduct periodic performance evaluations for direct reports in accordance with corporate policy.
Ensure timely project execution and quality deliverables; facilitate hand-off and kick-off meetings to identify risks and develop contingency plans.
Ensure project risks and contingencies affecting time, quality, or cost are discussed with customers and senior leaders through appropriate escalation pathways.
Serve as the initial escalation point for customer issues and communicate regularly with customers to obtain direction and feedback on scope and performance.
Identify significant problems encountered during clinical trials and propose strategies to prevent or correct them.